The following data is part of a premarket notification filed by Eye Garter Company, Inc. with the FDA for Blue Plastic Eye Shield.
| Device ID | K880490 |
| 510k Number | K880490 |
| Device Name: | BLUE PLASTIC EYE SHIELD |
| Classification | Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear) |
| Applicant | EYE GARTER COMPANY, INC. 8535 WEST BELLFORT Houston, TX 77071 |
| Contact | Goffman, Md |
| Correspondent | Goffman, Md EYE GARTER COMPANY, INC. 8535 WEST BELLFORT Houston, TX 77071 |
| Product Code | HOY |
| CFR Regulation Number | 886.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-02-04 |
| Decision Date | 1988-05-03 |